MAUDE Adverse Event Report: NOBEL BIOCARE AB NOBELREPLACE® TAPERED GROOVY RP 4.3X13MM; ENDOSSEOUS DENTAL IMPLANT

Model Number 29414

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924)

Event Date 03/02/2023

Event Type  Injury  

Event Description

The implant malfunctioned due to an engagement issue.The malfunction did not cause or contribute to a death or serious injury.

Event Description

The implant malfunctioned due to an engagement issue.The malfunction did not cause or contribute to a death or serious injury.The initial report did not have the correct event type documented, the correct event type, serious injury, is provided in this follow-up report.

• Brand Name: NOBELREPLACE® TAPERED GROOVY RP 4.3X13MM
• Type of Device: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• MDR Report Key: 16735414
• MDR Text Key: 313245835
• Report Number: 2027971-2023-063431
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 07332747159684
• UDI-Public: (01)07332747159684(10)12201775(17)270513
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 29414
• Device Catalogue Number: 32217
• Device Lot Number: 12201775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 04/13/2023
• Distributor Facility Aware Date: 03/29/2023
• Event Location: Outpatient Treatment Facility
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male